# K230897: Anterion

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering GmbH
- Decided: Oct 11, 2023 after 194 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K051789 (2005). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211817: Anterion, Heidelberg Engineering GmbH (2021) Summary page 6.

## Most influential descendants
- K240924: Anterion (2024), 1 descendant of its own
- K261019: Anterion (2026), 0 descendants of its own

## Indications for use
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length. The analysis covers: • Cornea Thickness • Anterior Segment o Anterior chamber width, depth, volume and angle parameters o Lens Thickness • Axial Length

Source page: https://510kreport.com/device/K230897
Methodology: https://510kreport.com/methodology